NEW YORK (Reuters Health) Jan 17 - In a small minority of patients with metastatic renal cell carcinoma, the tyrosine kinase inhibitors (TKIs) sunitinib or sorafenib prompt complete remission, European researchers report.
And some of those patients remain in remission after therapy stops.
"Complete remissions rarely occur with TKIs, but they sometimes do (1-2%). One important question is whether treatment should be continued or not when this phenomenon occurs," said Dr. Laurence Albiges, lead author of the report, in an email to Reuters Health.
Dr. Albiges of Institut Gustave Roussy, Villejuif, France and colleagues studied 64 patients who had a complete response to sunitinib or sorafenib, either alone or in combination with surgery, radiation, or radiofrequency ablation.
This group accounts for about 1.7% of patients treated for metastatic RCC with these agents at 14 centers in France and one in Switzerland, according to estimates by the authors.
Fifty-nine patients received sunitinib; the other five received sorafenib. Sixty had clear cell histology.
The protocol for sunitinib was 50 mg daily for four weeks, followed by two weeks off treatment. Patients on sorafenib took 800 mg daily, given continuously in four-week cycles. Both drugs could be given either as part of a trial, or in an approved setting.
Everyone had undergone nephrectomy. Most were of favorable or intermediate risk, but three of the patients had been considered high-risk, the authors noted in a January 9th online paper in the Journal of Clinical Oncology.
Thirty-six patients achieved remission with a TKI alone (i.e. without local treatment), after a median 12.6 months of therapy. Eight of those continued to take a TKI. Of the 28 who stopped, 17 (61%) are still in complete remission after a median follow-up of 255 days, according to the report.
Of the 28 patients who also received local treatment, 25 stopped taking their TKI - including 12 (48%) who remain in complete remission at a median follow-up of 322 days.
"Our study supports the possibility (of stopping) treatment with careful follow up," Dr. Albiges said. "With this strategy, relapse will occur in only half of the patients, and importantly, most of these patients will remain responsive to further rechallenge."
Because of the small number of patients in each group, say the investigators, "it was not possible to draw any conclusions about differences in relapse rates between patients who continued or stopped therapy."
They conclude that "stopping treatment with a TKI after complete remission may be an acceptable option" but "further research is also needed to identify factors to aid selection of patients who would be at less risk of recurrence after discontinuation."
SOURCE: http://bit.ly/yoM8u9
J Clin Oncol 2012.
And some of those patients remain in remission after therapy stops.
"Complete remissions rarely occur with TKIs, but they sometimes do (1-2%). One important question is whether treatment should be continued or not when this phenomenon occurs," said Dr. Laurence Albiges, lead author of the report, in an email to Reuters Health.
Dr. Albiges of Institut Gustave Roussy, Villejuif, France and colleagues studied 64 patients who had a complete response to sunitinib or sorafenib, either alone or in combination with surgery, radiation, or radiofrequency ablation.
This group accounts for about 1.7% of patients treated for metastatic RCC with these agents at 14 centers in France and one in Switzerland, according to estimates by the authors.
Fifty-nine patients received sunitinib; the other five received sorafenib. Sixty had clear cell histology.
The protocol for sunitinib was 50 mg daily for four weeks, followed by two weeks off treatment. Patients on sorafenib took 800 mg daily, given continuously in four-week cycles. Both drugs could be given either as part of a trial, or in an approved setting.
Everyone had undergone nephrectomy. Most were of favorable or intermediate risk, but three of the patients had been considered high-risk, the authors noted in a January 9th online paper in the Journal of Clinical Oncology.
Thirty-six patients achieved remission with a TKI alone (i.e. without local treatment), after a median 12.6 months of therapy. Eight of those continued to take a TKI. Of the 28 who stopped, 17 (61%) are still in complete remission after a median follow-up of 255 days, according to the report.
Of the 28 patients who also received local treatment, 25 stopped taking their TKI - including 12 (48%) who remain in complete remission at a median follow-up of 322 days.
"Our study supports the possibility (of stopping) treatment with careful follow up," Dr. Albiges said. "With this strategy, relapse will occur in only half of the patients, and importantly, most of these patients will remain responsive to further rechallenge."
Because of the small number of patients in each group, say the investigators, "it was not possible to draw any conclusions about differences in relapse rates between patients who continued or stopped therapy."
They conclude that "stopping treatment with a TKI after complete remission may be an acceptable option" but "further research is also needed to identify factors to aid selection of patients who would be at less risk of recurrence after discontinuation."
SOURCE: http://bit.ly/yoM8u9
J Clin Oncol 2012.
Δεν υπάρχουν σχόλια:
Δημοσίευση σχολίου